Recall Z-2121-2012— Perkinelmer

Name: FDA recall Z-2121-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-27

Class II · Terminated

Class II FDA medical device recall by Perkinelmer, initiated 2012-06-27, terminated 2014-04-18. It names one FDA 510(k) clearance: K090846. Product: Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The reagent kits running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Currently assays for the determination of T4, TSH, 17OHP, IRT and GALT are cleared and available for use with the GSP instrument.. Reason: Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for Genetic Screening for Neonatal IRT, TSH and IRT.

Recalling firm: Perkinelmer
Classification: Class II
Status: Terminated
Initiated: 2012-06-27
Terminated: 2014-04-18
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K090846 — GSP INSTRUMENT AND GSP NEONATAL HTSH KITPerkinelmer, Inc.·cleared 2009-09-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The reagent kits running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Currently assays for the determination of T4, TSH, 17OHP, IRT and GALT are cleared and available for use with the GSP instrument.

Reason for recall

Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for Genetic Screening for Neonatal IRT, TSH and IRT

Data sourced from openFDA. This site is unofficial and independent of the FDA.